# FDA 483 - Atlantic Bakery Ltd. - February 25, 2021

Source: https://www.keypedia.com/records/483/atlantic-bakery-ltd/1fe18a11-a67a-4833-bd00-4da5db887289

> FDA 483 for Atlantic Bakery Ltd. on February 25, 2021. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Atlantic Bakery Ltd.
- Inspection Date: 2021-02-25
- Product Type: Food
- Office Name: Food and Drug Administration
- Summary: An FDA inspection conducted at Atlantic Bakery Ltd., a ready-to-eat bread and pastry manufacturer in Delray Beach, FL, from February 9 to February 25, 2021, revealed several significant deficiencies. The observations indicate non-compliance with current Good Manufacturing Practices and Food Safety Modernization Act requirements for preventive controls. Key violations included the absence of adequate written procedures for monitoring allergen controls, particularly regarding shared equipment for products containing nuts, dairy, egg, and soy. The bakery also lacked sufficient environmental monitoring verification, failing to specify sampling locations for ATP testing or collect microbiological swabs for Listeria and Salmonella. Repeated observations noted inadequate cleaning and sanitation of equipment, with flour and dough buildup, and poorly designed equipment that could not be adequately cleaned, posing contamination risks. Furthermore, the firm's hazard analysis was deficient, failing to identify potential metal inclusion hazards or assess risks like allergen cross-contact and recontamination during post-bake slicing and packaging steps. Other issues included a lack of written procedures for monitoring baking process controls and proper supplier verification for high-risk ingredients like wheat flour and tree nuts for mycotoxins. Finally, sanitation control records were not reviewed within appropriate timeframes by a qualified, independent individual. Atlantic Bakery Ltd. must implement comprehensive corrective actions to address these systemic issues and ensure food safety and regulatory compliance.

## Related Documents

- [483 - 2021-02-25](https://www.keypedia.com/records/483/atlantic-bakery-ltd/a0e994b8-0e9b-405b-a326-0a927a09133a)

## Related Officers

- [Owner](https://www.keypedia.com/people/william-b-himmelrich/4b5f484c-ba5c-4dd8-925b-b5be5a130589)
- [Gina Eng](https://www.keypedia.com/people/gina-eng/7f421a03-468f-4f86-9889-9bdc9460f72f)
- [Director of Compliance Branch](https://www.keypedia.com/people/gina-brackett/fa52f03a-8a7e-485e-8773-a1da3fa628d7)

Company: https://www.keypedia.com/companies/atlantic-bakery-ltd/16da937b-88c9-40f1-897e-4db8fb177a15

Office: https://www.keypedia.com/offices/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516